The following data is part of a premarket notification filed by Popper & Sons, Inc. with the FDA for Hypodermic Needles, Single Lumen.
Device ID | K911397 |
510k Number | K911397 |
Device Name: | HYPODERMIC NEEDLES, SINGLE LUMEN |
Classification | Biopsy Needle |
Applicant | POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
Contact | Joseph A Popper |
Correspondent | Joseph A Popper POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-29 |
Decision Date | 1991-05-20 |